MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL® INFANT CATH KIT

Model Number	0035630
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the baby was inserted with a straight catheter and the tubing leaked.This resulted in contaminated urine and the baby needed another straight catheter.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the baby was inserted with a straight catheter and the tubing leaked.This resulted in contaminated urine and the baby needed another straight catheter.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "cap of the centrifuge tube too tigth obstruction in tube kinked tubing wrong tubing dimensions tubing does not meet specification".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warnings: the catheter should never be forced if resistance is felt.Trauma to the bladder (false passage) can be prevented by adequately lubricating the catheter and stretching the penis to straighten the urethra.Sterile: sterile unless package is opened or damaged.Instructions: 1.Open plastic wallet, which may be used as a sterile field.The following four steps apply only to male catheterization: 2.Place the infant supine, with the thighs abducted (frog-leg position).3.Cleanse the penis with povidone-iodine swabs, starting with the meatus and moving in a proximal direction.4.Put on sterile gloves.Remove protective sheath from catheter and pull catheter out of centrifuge tube to desired length.Lay tube assembly on the sterile field.5.Place the tip of the catheter in sterile lubricant.Hold the penis perpendicular to the body to straighten the penile urethra and help prevent false passage.Advance the catheter carefully until urine appears.A slight resistance may be felt as the catheter passes the external sphincter.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.6.After urine is collected, pull catheter out of the cap of the centrifuge tube.Tighten cap and depress spout.7.Fill out label and place on centrifuge tube.Send to lab in normal manner.The following four steps apply only to female catheterization: 2.Place the infant supine, with the thighs abducted (frog-leg position).3.Separate the labia and cleanse the area around the meatus with the povidone-iodine swabs.Use anterior-to-posterior strokes to prevent fecal contamination.4.Put on sterile gloves.Remove protective sheath from catheter and pull catheter out of centrifuge tube to desired length.Lay tube assembly on the sterile field.5.Place the tip of the catheter in sterile lubricant.Spread the labia with two fingers and carefully advance the catheter until urine appears.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.6.After urine is collected, pull catheter out of the cap of the centrifuge tube.Tighten cap and depress spout.7.Fill out label and place on centrifuge tube.Send to lab in normal manner." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: DAVOL® INFANT CATH KIT
• Common Device Name: INFANT CATH KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12853389
• Report Number: 1018233-2021-07424
• Device Sequence Number: 5823615
• Product Code: FFH
• UDI-Device Identifier: 00801741045844
• UDI-Public: (01)00801741045844
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 0035630
• Device Catalogue Number: 0035630
• Device Lot Number: NGFU2496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown